Recall Z-1936-2024— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1936-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-17

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYNJSYRPP10R; e) SYRINGE 10ML GREEN L/L LOW PR, Item Number: DYNJSYRPP10G; f) SYRINGE 10ML WHITE L/L LOW PR, Item Number: DYNJSYRPP10W; g) SYRINGE CNTRL 10ML RED L/L LP, Item Number: DYNJSYCPP10R; h) SYRINGE 5ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP5Y; i) SYRINGE CNTRL 10ML YEL L/L LP, Item Number: DYNJSYCPP10Y; j) SYRINGE 3ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP3Y; k) SYRINGE 5ML WHITE L/L LOW PR, Item Number: DYNJSYRPP5W; l) SYRINGE,CONTROL,LL,FINGER GRIPS,10ML, Item Number: DYNJPOLYCON1. Reason: These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-04-17
Firm location: Northfield, IL, United States

Product description

Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYNJSYRPP10R; e) SYRINGE 10ML GREEN L/L LOW PR, Item Number: DYNJSYRPP10G; f) SYRINGE 10ML WHITE L/L LOW PR, Item Number: DYNJSYRPP10W; g) SYRINGE CNTRL 10ML RED L/L LP, Item Number: DYNJSYCPP10R; h) SYRINGE 5ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP5Y; i) SYRINGE CNTRL 10ML YEL L/L LP, Item Number: DYNJSYCPP10Y; j) SYRINGE 3ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP3Y; k) SYRINGE 5ML WHITE L/L LOW PR, Item Number: DYNJSYRPP5W; l) SYRINGE,CONTROL,LL,FINGER GRIPS,10ML, Item Number: DYNJPOLYCON1

Reason for recall

These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.

Data sourced from openFDA. This site is unofficial and independent of the FDA.